Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects

NCT02189200 | Completed DMC

• 1 other identifier: 03131712.3.0000.5265
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse events with statins, added to recent questions about their benefits on hard outcomes, opens a gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary fibers with supposed action in reducing the absorption of exogenous cholesterol and the endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of atherosclerotic disease.

Conditions

Dietary Modification

Keywords

nutritional counseling; oat bran; dyslipidemia; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in LDL-cholesterol in three months

  mesures assessed in baseline, after 30, 60 and 90 days

Secondary Outcomes (1)

• Change from baseline in glucose profile in three months

  mesures assessed in baseline, after 30, 60 and 90 days

Other Outcomes (3)

• Change from baseline in body mass

  mesures in kg, assessed in baseline, after 30, 60 and 90 days

• Change from baseline in waist circumference

  mesures in cm, assessed in baseline, after 30, 60 and 90 days

• Change from baseline in neck circumference

  mesures in cm, assessed in baseline, after 30, 60 and 90 days

Study Arms (2)

Oat bran group

ACTIVE COMPARATOR

oat bran (40g per day)

Dietary Supplement: oat bran - 40g

Placebo group

PLACEBO COMPARATOR

refined rice flour (40g per day)

Dietary Supplement: refined rice flour- 40g

Interventions

oat bran - 40g DIETARY_SUPPLEMENT

oat bran - 40g per day

Oat bran group

refined rice flour- 40g DIETARY_SUPPLEMENT

refined rice flour - 40g per day

Placebo group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL-c equal or higher than 130mg/dL fasting lipemia.

You may not qualify if:

• patients requiring reduction in daily fluid intake
• patients in use of dietary fiber supplements
• gestation
• lactation

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Instituto Estadual de Cardiologia Aloysio de Castro - IECAC

Rio de Janeiro, Rio de Janeiro, 22261-010, Brazil

Location

Related Publications (25)

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• Yang J, Ou B, Wise ML, Chu Y. In vitro total antioxidant capacity and anti-inflammatory activity of three common oat-derived avenanthramides. Food Chem. 2014 Oct 1;160:338-45. doi: 10.1016/j.foodchem.2014.03.059. Epub 2014 Mar 21.

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Related Links

• WORLD HEALTH ORGANIZATION. Cardiovascular disease prevention and control. Translating evidence into action, 2005
• WORLD HEALTH ORGANIZATION. Prevention of cardiovascular disease: guidelines for assessment and management of total cardiovascular risk, 2007

MeSH Terms

Conditions

Dyslipidemias; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Simone R. Souza

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra.

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 14, 2014
• Study Start: October 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

BR (1)